Key result
Genous stent shows no benefit over Taxus stent for target vessel failure in high-risk lesions.
Why the study?
The comparative performance of the Genous endothelial progenitor cell capturing stent versus the Taxus Liberté paclitaxel-eluting stent in patients with high-risk de novo coronary lesions was not established.
Does the Genous endothelial progenitor cell capturing stent reduce target vessel failure compared to the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary lesions at high risk of restenosis?
RCT (n=193)
No
Does the Genous endothelial progenitor cell capturing stent reduce target vessel failure compared to the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary lesions at high risk of restenosis?
In patients with high-risk coronary lesions, the Genous stent resulted in a non-significant higher rate of target vessel failure compared with the Taxus stent, mainly driven by more repeat revascularizations, though it had numerically fewer stent thromboses.
May not support Genous over Taxus in high-risk lesions; leaves open comparative efficacy in larger trials.
AIMS: The purpose of this study was to evaluate the Genous(TM) endothelial progenitor cell capturing stent vs. the Taxus Liberté paclitaxel-eluting stent in patients with de novo coronary lesions with a high-risk of coronary restenosis. METHODS AND RESULTS: We randomly assigned 193 patients with lesions carrying a high risk of restenosis to have the Genous stent or the Taxus stent implanted. Lesions were considered high risk of restenosis if one of the following applied: chronic total occlusion, lesion length >23 mm, vessel diameter <2.8 mm, or any lesion in a diabetic patient. At 1-year, the rate of the primary end point, target vessel failure (TVF), was 17.3% in the Genous stent group when compared with 10.5% in the Taxus stent group [risk difference (RD) 6.8%, 95% CI -3.1 to 16.7%], a difference predominantly due to a higher incidence of repeat revascularization in patients treated with the Genous stent. In contrast, no stent thrombosis was observed in the Genous stent group compared to 4 stent thromboses in the Taxus stent group (RD -4.2%; 95% CI -10.3 to 0.3%). Repeat angiography between 6 and 12 months in a subgroup of patients showed a significantly higher late loss in the Genous stent compared with the Taxus stent (1.14 +/- 0.64 and 0.55 +/- 0.61 mm). CONCLUSION: In patients with lesions carrying a high risk of restenosis, the Genous stent resulted in a non-significant higher rate of TVF compared with the Taxus stent mainly due to more repeat revascularizations in the Genous stent group. There were four stent thromboses with Taxus stent, none with the Genous stent.
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Beijk et al. (2009) conducted an RCT in de novo coronary lesions with a high-risk of coronary restenosis (n=193). Genous endothelial progenitor cell capturing stent vs. Taxus Liberté paclitaxel-eluting stent was evaluated on target vessel failure (TVF) (RD 6.8%, 95% CI -3.1 to 16.7%). In patients with high-risk coronary lesions, the Genous stent resulted in a non-significant higher rate of target vessel failure at 1 year compared with the Taxus stent (17.3% vs 10.5%; RD 6.8%).
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